A Phase 2 Study of TRC105 in Patients With Recurrent Glioblastoma (GBM)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Radiographic Response Rate for Patients With Recurrent Glioblastoma Multiforme (GBM) Treated With TRC105.
研究概览
简要总结
Background:
- Glioblastoma is an aggressive type of brain cancer that often resists treatment. TRC105 is an experimental drug that blocks the growth of new blood vessels. It is being studied for possible use in treating different kinds of cancer. Researchers want to see if TRC105 can be used to treat glioblastoma that has not responded to standard treatments.
Objectives:
- To test the safety and effectiveness of TRC105 in adults who have glioblastoma that has not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age who have glioblastoma that has not responded to standard treatments.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and other tests will be used to study the tumor before the start of treatment.
- Participants will have 28-day (4-week) cycles of treatment.
- Participants will have TRC105 intravenously once a week. The first infusion will take about 4 hours. The length of time needed for the infusion may be slowly reduced if it is well tolerated.
- At the end of the first cycle (the first 4 weeks), the imaging studies will be repeated before continuing TRC105.
- Participants will take TRC105 for as long as the tumor does not grow and the side effects are not too severe. They will have imaging studies at the end of every cycle to evaluate the tumor.
详细描述
Background:
- TRC105 is an anti-angiogenic monoclonal antibody (mAb) that binds to CD105 (Endoglin), a transmembrane glycoprotein that is essential for angiogenesis, and expressed abundantly on activated vascular endothelial cells (ECs). CD105 is a member of the transforming growth factor-Beta (TGF-Beta) receptor superfamily, and modulates TGF-Beta signaling leading to EC proliferation and migration.
- Immunohistochemistry studies reveal that CD105 is preferentially expressed in blood vessels of tumor tissues as compared with normal mucosa. For patients with glioblastoma multiforme (GBM), increased expression of CD105 may correspond to worse survival times. Furthermore, expression of CD105 is essential for neovascularization, and is upregulated in the setting of (vascular endothelial growth factor ) VEGF inhibition.
- TRC105 binding to CD105 leads to inhibition of EC proliferation, neovascularization, and induces cell death via apoptosis. TRC105 may also mediate antibody-dependent cellular cytotoxicity (ADCC).
Objectives:
Primary
- To determine the radiographic response rate for patients with recurrent GBM treated with TRC105.
- To establish data regarding the anti-tumor activity of TRC105 in patients with GBM, as determined by progression free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TRC105 for Recurrent Glioblastoma
干预措施: TRC105 (Drug)
结局指标
主要结局
Radiographic Response Rate for Patients With Recurrent Glioblastoma Multiforme (GBM) Treated With TRC105.
时间窗: 14 months
Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is \>/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a \>/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,
次要结局
- Number of Participants With Adverse Events(5 months, 28 days)
研究者
Joohee Sul, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)